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Teduglutide

Revestive

Extended indication Revestive is indicated for the treatment of patients 4 months corrected gestational age 1 year and a
Therapeutic value No estimate possible yet
Registration phase Positive CHMP opinion

Product

Active substance Teduglutide
Domain Chronic immune diseases
Reason of inclusion Indication extension
Main indication Bowel diseases
Extended indication Revestive is indicated for the treatment of patients 4 months corrected gestational age 1 year and above with Short Bowel Syndrome (SBS). Patients should be stable folllowing a period of intestinal adaptation after surgery.
Proprietary name Revestive
Manufacturer Takeda
Mechanism of action Glucagon analogue
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Extramural (GVS)

Registration

Registration route Centralised (EMA)
Submission date February 2022
Expected Registration June 2023
Orphan drug Yes
Registration phase Positive CHMP opinion
Additional remarks Positieve CHMP-opinie in april 2023

Therapeutic value

Therapeutic value No estimate possible yet
Substantiation Op termijn is er mogelijk een plaats voor teduglutide bij een bepaalde groep patiënten met short bowel syndroom. Op dit moment is er geen uitspraak te doen over de therapeutische waarde.
Frequency of administration 1 times a day
Dosage per administration 0.05 mg per kg body weight
References NCT03571516

Expected patient volume per year

References Expert opinie;
Additional remarks Er wordt voorlopig geen groot patiëntvolume verwacht voor deze indicatie.

Expected cost per patient per year

References https://www.drugs.com/price-guide/gattex
Additional remarks Prijs in Nederland is nog niet bekend. De kosten voor Teduglutide subcutane kit 5 mg is ongeveer $1.794, wat ongeveer €1.678,77 is. Over het algemeen liggen de prijzen in de US hoger voor geneesmiddelen dan in Nederland.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.